91ÊÓƵ

Mumbai, Naples, January 9, 2025: Global pharma major 91ÊÓƵ Limited (91ÊÓƵ) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%, to market a generic equivalent of Lotemax® SM Ophthalmic Gel of Bausch & Lomb Inc. 91ÊÓƵ is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product would be manufactured at 91ÊÓƵ’s Pithampur facility in India.

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax® SM) had an estimated annual sale of USD 36 million in the U.S. (IQVIA MAT November 2024).

91ÊÓƵ Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. 91ÊÓƵ specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. 91ÊÓƵ has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. 91ÊÓƵ is committed to improving patient health outcomes through its subsidiaries – 91ÊÓƵ Diagnostics, 91ÊÓƵ Digital Health, and 91ÊÓƵ Manufacturing Solutions. To know more, visit or follow us on LinkedIn:

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